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NCT03089112 Clinical Trial

Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501

Healthy Male Volunteers Clinical Trial

Official title:
A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and the Safety Between HGP1607 and HGP1501 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03089112
Other study ID # HM-BAVI-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 31, 2017
Est. completion date June 16, 2017

Study information
Verified date November 2022
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 16, 2017
Est. primary completion date May 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria: - 1.age 19~40 years - 2.The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2 - 3.Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: 1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system 2. Subjects who judged ineligible by the investigator

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HGP1607
Take it once per period
• HGP1501
Take it once per period
• HGP1607+HGP1501
Take it once per period

Locations
Country Name City State
Korea, Republic of Seoul Asan Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUClast of HGP1607 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Primary Cmax of HGP1607 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Primary baseline corrected AUClast of HGP1501 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Primary baseline corrected Cmax of HGP1501 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Secondary AUCinf of HGP1607 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Secondary Tmax of HGP1607 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Secondary T1/2 of HGP1607 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Secondary AUClast of HGP1501 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Secondary Cmax of HGP1501 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Secondary baseline corrected AUCinf of HGP1501 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Secondary baseline corrected Tmax of HGP1501 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Secondary baseline corrected T1/2 of HGP1501 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
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